Posttraumatic Stress DisorderNCT04230668
Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder and Borderline Personality Disorder (PTSD-BPD)
A study testing Cognitive Processing Therapy with Suicide Risk Management and Treatment as Usual with Suicide Rick Management in people with Posttraumatic Stress Disorder and Borderline Personality Disorder, run by Palo Alto University at 1 site in United States.
Trial summary
Posttraumatic Stress Disorder (PTSD) with co-occurring Borderline Personality Disorder (BPD) (i.e., PTSD-BPD) is common (as high as 58%), debilitating, costly, and limited treatment options available for this population. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder, Borderline Personality Disorder
- What is being tested?
- Cognitive Processing Therapy with Suicide Risk Management and Treatment as Usual with Suicide Rick Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years
- Must reside in the Bay Area, CA
- Current DSM-5 diagnosis of PTSD and BPD
- Must be willing to be audio- or videorecorded for assessment and treatment sessions
Who cannot join
- Acute mania, acute psychosis, or intellectual disability
- Conditions requiring medical attention to a potentially life-threatening illness (e.g., severe anorexia nervosa)
- Severe impairments in written and aural comprehension
- EU individuals
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Palo Alto University
Palo Alto, California, 94304
Ariana Guenther, B.A. (Hons), 650-485-1513, bestlab@paloaltou.edu
About this study
Official title: A Pilot Effectiveness Trial of Cognitive Processing Therapy Augmented With Suicide Risk Management for Individuals With Comorbid PTSD and BPD
Posttraumatic Stress Disorder (PTSD) with co-occurring Borderline Personality Disorder (BPD) (i.e., PTSD-BPD) is common (as high as 58%), debilitating, costly, and limited treatment options available for this population. PTSD-BPD is associated with even greater functional impairment and higher healthcare burden than either disorder alone. There are surprisingly few treatments available for this clinical profile, despite its association with major negative health outcomes, cost, and morbidity. There is a pressing need to innovate treatments that can effectively and efficiently treat PTSD-BPD. The existing treatments used for PTSD-BPD are lengthy, laborious, resource-intensive, and require complete cessation of suicidal behaviors prior to treatment. Furthermore, no integrated treatment has been innovated to deliver the active ingredients to efficiently affect the mechanisms underpinning this comorbidity. The investigators propose to examine an adapted version of a first-line PTSD intervention, Cognitive Processing Therapy, augmented with a Suicide Risk Management, i.e., (CPT+SRM) as a brief (12 sessions) and more parsimonious treatment alternative that strategically targets shared mechanisms underpinning PTSD and BPD. The purpose of this pilot study is to 1) collect initial feasibility, acceptability, and safety data on this adapted treatment, 2) conduct a pilot randomized clinical trial evaluating the efficacy of CPT+SRM versus Treatment as Usual (TAU) + SRM, and 3) evaluate two targets (i.e, improvements in emotional intensity and cognitive dysfunction) as mechanisms leading to change in our primary outcomes. Both treatment conditions will be administered via telehealth.
Potential benefits include reduction in participants' PTSD, BPD and other mental health symptoms. Additionally, this work could benefit the community by improving the treatment repertoire for PTSD-BPD. Potential risks include emotional distress, suicidality, and/or self-harm. Participants may experience discomfort and/or distress while discussing participants trauma(s) and mental health. These risks will be mitigated using a suicide risk management protocol which therapists in the assessment of risk and protective factors of suicide, followed by documentation for the decision-making around the management of risk.
- Being tested
- Cognitive Processing Therapy with Suicide Risk Management, Treatment as Usual with Suicide Rick Management
- Keywords
- Cognitive Processing Therapy, Suicide Risk Management, Suicide, Self-harm
- Medical subject headings
- Stress Disorders, Post-Traumatic, Borderline Personality Disorder, Suicide, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Processing Therapy with Suicide Risk ManagementBehavioural
CPT is an evidence-based treatment for PTSD. This first-line treatment for PTSD will be adapted and combined with SRM into 12 sessions, 60-90 minutes targeting both PTSD and BPD. Individuals assigned to this intervention will attend treatment sessions, and be asked to do treatment homework at home. The primary outcomes are PTSD and BPD severity.
Treatment as Usual with Suicide Rick ManagementBehavioural
In the Suicide Risk Management only condition, participants will receive 6 weekly sessions over the course of six weeks focused on suicide stabilization and management. Each SRM session will be variable lengths, depending on the participants' suicide risk and can be up to 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| CPT + SRM | Experimental | Participants will be randomized to teletherapy sessions of Cognitive Processing Therapy + Suicide Risk Management for PTSD-BPD which will be administered twice weekly over 6 weeks, for a total of 12 sessions. Receives: Behavioral: Cognitive Processing Therapy with Suicide Risk Management |
| TAU + SRM | Experimental | Participants will be randomized to teletherapy sessions with only Suicide Risk Management for PTSD-BPD which will be administered once a week for 6 weeks, for a total of 6 sessions. Receives: Behavioral: Treatment as Usual with Suicide Rick Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
A 30-item clinician administered structured interview based on the DSM-5 PTSD criteria.
Measured: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Borderline Symptom List 23 (BSL-23) [SELF-REPORT]
A self-report measure of borderline personality disorder (BPD) severity. The measure captures subjective ratings of the following symptoms: self-perception, affect regulation, self destruction, dysphoria, loneliness, intrusions, and hostility (Bohus et al., 2009).
Measured: Baseline, once a week while in treatment (for 6 weeks)
Secondary outcomes (27)
Suicide Attempt Self-Injury Interview (SASII)
Assess characteristics of self-harm (i.e., suicide attempts and NSSI), including frequency, medical severity, intent to die, lethality, and precipitants of self-harm since the previous assessment.
Measured: 3-weeks, Post-treatment/6-weeks, 3-month follow-up
Difficulties in Emotion Regulation Scale (DERS) [SELF-REPORT]
A self-report measure assessing various dimensions of emotion dysregulation (Gratz \& Roemer, 2004).
Measured: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Posttraumatic Cognitions Inventory (PTCI) [SELF-REPORT]
A 33-item scale assessing post-traumatic symptoms, reactions and appraisals. The measure possesses three subscales; negative cognitions related to the self, negative cognitions related to the world, and self-blame cognitions related to the traumatic event.
Measured: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Beck's Depression Inventory-II (BDI-II) [SELF-REPORT]
A 21-item, self-report inventory that measures the severity of depression symptomatology. It corresponds closely to DSM-5 depression criteria and is found to be a more reliable measure of depression (Beck \& Steer, 1988).
Measured: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
State-Trait Anxiety Inventory, Trait Version (STAI-T)
A measure that consists of 20 items for assessing trait anxiety and 20 for assessing state anxiety. It is used to diagnose anxiety and to help distinguish it from depressive syndromes.
Measured: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
State-Trait Anger Expression Inventory-II (STAXI-II) [SELF-REPORT]
A 57-item self-report measure that examines the expression, control, and experience of anger (Schamborg, Tully, \& Browne, 2016).
Measured: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Social Adjustment Scale - Self Report (SAS-SR) [SELF-REPORT]
A measure that consists of 54 items for assessing role performance in six areas of functioning, including work, social and leisure activities, relationships with extended family, role as a marital partner (if applicable), parental role (if applicable), and role within the family unit.
Measured: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Trauma-Related Guilt Inventory (TRGI) [SELF-REPORT]
A 32-item self-report measure that is designed to measure guilt experienced as a result of a traumatic event. It is composed of three subscales including; guilt cognitions, distress and global guilt.
Measured: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Suicidal Behaviors Questionnaire-Revised
Scores range from 3 to 18, with 18 being higher suicide risk.
Measured: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Substance Use Inventory (SUI)
A brief measure with detailed questions regarding participants' use and primary route of different substances they used in the last seven days. The individuals' are also asked about the average dollar amount spent on each drug and in a single day. (Weiss, et al., 1995).
Measured: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
PTSD Checklist-5 (PCL-5) [SELF-REPORT]
A 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. It is used to help screen individuals for PTSD as well as monitor their symptom changes during and after treatment.
Measured: Baseline, once a week while in treatment (for 6 weeks)
Acceptability of Intervention Measure (AIM)
A 4-item measure which asks therapists and patients about their perceived acceptability of the intervention on a 5-point Likert scale.
Measured: Baseline and Post-treatment/6-weeks
Treatment sessions attended
Feasibility as measured by number of treatment sessions
Measured: Pre-post treatment (6 weeks)
Rate of dropout
Feasibility as measured by rate of treatment dropout
Measured: Pre-post treatment (6 weeks)
Emotional Reactivity and Attentional Biases via Oddball task
Used as a behavioral measure of changes in emotional reactivity and attentional biases- our two propose mechanisms of change in CPT+SRM. The oddball task is computer-based task (Hayes, et al., 2009) designed to measure emotional reactivity and attentional biases. Participants will view a pseudorandom distribution of brief presentations of emotionally-salient distractors (negative images depicting mutilations, burn victims, attacks, sick individuals), neutral distractors (matched with negative images for luminance, presence of human figures, chromatic features), baseline standards (squares), and attention "targets" (circles) in an event-related design. Participants will be instructed to press the same button for all stimuli, but a different button for attention targets. Behavioral changes associated with emotional reactivity and attention bias will be assessed using response latency and accuracy scores for emotional and attention targets, respectively.
Measured: Baseline, Post-treatment/6-weeks, 3-months follow-up
Mental Health Involvement Scale [SELF-REPORT]
A 9-item measure used to inquire about other ancillary services (e.g., group treatment, couples/family therapy) that participants are receiving throughout the study. This is a measure developed and used in prior research by the investigative team, but currently does not have published psychometric properties.
Measured: Post-treatment/6-weeks
Measure of CPT+SRM Uptake [SELF-REPORT]
Measures uptake of the treatment using an adapted measure from LoSavio, et al. (2019). This brief survey will assess clinicians' ongoing use of CPT+SRM since their participation in the study (e.g., whether they continue to offer CPT+SRM, the number of clients they have offered CPT+SRM to, average number of sessions attended, etc.) and further inform whether our training methods and treatment will have a lasting impact on practice approaches in community settings. There are no psychometric data available for this questionnaire.
Measured: 9-months after concluding treatment with the last study participant
Unanticipated Problems Involving Risk to Subjects or Others (UPIRSO)
Safety of the treatment will be monitored via unanticipated problems involving risk to subjects or others (UPIRSO) that occur throughout treatment and the number of mental health hospitalizations.
Measured: Baseline, 3-weeks, Post-treatment/6-weeks
The International Personality Disorder Exam (IPDE, BPD only)
A well-established diagnostic instrument used by the World Health Organization, will be used to identify the presence and severity of BPD. The IPDE also allows for a dimensional assessment of BPD.
Measured: Baseline
The Structured Clinical Interview for the Diagnostic and Statistical Manual-5 (SCID-5)
Used to obtain other DSM-5 diagnoses.
Measured: Baseline
The Lifetime Suicide Attempt Self-Injury Interview (L-SASII)
A semi-structured interview, will assess characteristics of self-harm (i.e., suicide attempts and NSSI), including frequency, medical severity, intent to die, lethality, and precipitants of self-harm.
Measured: Baseline
A Demographic Form [SELF-REPORT]
Used in previous PTSD treatment studies will also be used to measure a range of demographic data.
Measured: Baseline
Trauma-Related Shame Inventory (TRSI) [SELF-REPORT] Trauma-Related Shame Inventory (TRSI) [SELF-REPORT]: is a 24-item self-report measure that evaluates levels of shame in the context of one's trauma. --
A 24-item self-report measure that evaluates levels of shame in the context of one's trauma.
Measured: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Patient Health Questionnaire - 9 (PHQ-9)
A 9-item self-report measure that evaluates severity of depression symptoms.
Measured: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Generalized Anxiety Disorder - 7 (GAD7)
A 7-item self-report measure that evaluates severity of generalized anxiety symptoms.
Measured: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
WHO Disability Assessment Schedule (WHODAS) 2.0 (12-Item Version)
A 12-item self-report measure of disability across six domains (understanding and communicating, getting around, self-care, getting along with people, life activities, and participation in society).
Measured: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure-Adult
A 23-item self-report measure of psychiatric symptoms that cut across diagnostic categories.
Measured: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Oct 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-phased study. Phase 1 of this investigation will consist of an initial case series in which the CPT+SRM manual will be developed along with fidelity measures. The finalized treatment manual will then be tested in Phase 2, a randomized-controlled trial comparing 12 individual sessions/6 weeks of CPT+SRM versus 6 weeks of TAU+SRM.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Palo Alto University
- Sponsor type
- University, hospital or other
- Collaborators
- Toronto Metropolitan University, York University, Stanford University, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Janice Kuo, Palo Alto University
- Investigators
- Janice R Kuo, PhD, Principal investigator, Palo Alto University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230668
- Sponsor's protocol ID
- CPT for PTSD-BPD
- Other IDs
- 1R34MH124968-01A1
- Status last verified
- Jan 2024
- First submitted
- 9 Jan 2020
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Resick, P. A., Monson, C. M., & Chard, K. M. (2016). Cognitive processing therapy for PTSD: A comprehensive manual. New York, NY: Guilford Press.
Stanley, B., & Brown, G. (2012). Safety planning intervention: A brief intervention to mitigate suicide risk. Cognitive and Behavioural Practice, 19(2), 256-264.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Effectiveness Trial of Cognitive Processing Therapy Augmented With Suicide Risk Management for Individuals With Comorbid PTSD and BPD
- ClinicalTrials.gov ID
- NCT04230668
- Acronym / sponsor ID
- CPT for PTSD-BPD
- Keywords
- Cognitive Processing Therapy, Suicide Risk Management, Suicide, Self-harm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Palo Alto UniversityUniversity, hospital or other
- Collaborators
- Toronto Metropolitan University, York University, Stanford University, National Institute of Mental Health (NIMH)
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Posttraumatic Stress Disorder (PTSD) with co-occurring Borderline Personality Disorder (BPD) (i.e., PTSD-BPD) is common (as high as 58%), debilitating, costly, and limited treatment options available for this population. PTSD-BPD is associated with even greater functional impairment and higher healthcare burden than either disorder alone. There are surprisingly few treatments available for this clinical profile, despite its association with major negative health outcomes, cost, and morbidity. There is a pressing need to innovate treatments that can effectively and efficiently treat PTSD-BPD. The existing treatments used for PTSD-BPD are lengthy, laborious, resource-intensive, and require complete cessation of suicidal behaviors prior to treatment. Furthermore, no integrated treatment has been innovated to deliver the active ingredients to efficiently affect the mechanisms underpinning this comorbidity. The investigators propose to examine an adapted version of a first-line PTSD intervention, Cognitive Processing Therapy, augmented with a Suicide Risk Management, i.e., (CPT+SRM) as a brief (12 sessions) and more parsimonious treatment alternative that strategically targets shared mechanisms underpinning PTSD and BPD. The purpose of this pilot study is to 1) collect initial feasibility, acceptability, and safety data on this adapted treatment, 2) conduct a pilot randomized clinical trial evaluating the efficacy of CPT+SRM versus Treatment as Usual (TAU) + SRM, and 3) evaluate two targets (i.e, improvements in emotional intensity and cognitive dysfunction) as mechanisms leading to change in our primary outcomes. Both treatment conditions will be administered via telehealth.
Potential benefits include reduction in participants' PTSD, BPD and other mental health symptoms. Additionally, this work could benefit the community by improving the treatment repertoire for PTSD-BPD. Potential risks include emotional distress, suicidality, and/or self-harm. Participants may experience discomfort and/or distress while discussing participants trauma(s) and mental health. These risks will be mitigated using a suicide risk management protocol which therapists in the assessment of risk and protective factors of suicide, followed by documentation for the decision-making around the management of risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a two-phased study. Phase 1 of this investigation will consist of an initial case series in which the CPT+SRM manual will be developed along with fidelity measures. The finalized treatment manual will then be tested in Phase 2, a randomized-controlled trial comparing 12 individual sessions/6 weeks of CPT+SRM versus 6 weeks of TAU+SRM.
| Arm | Type | Receives |
|---|---|---|
| CPT + SRM | Experimental | Behavioral: Cognitive Processing Therapy with Suicide Risk ManagementParticipants will be randomized to teletherapy sessions of Cognitive Processing Therapy + Suicide Risk Management for PTSD-BPD which will be administered twice weekly over 6 weeks, for a total of 12 sessions. |
| TAU + SRM | Experimental | Behavioral: Treatment as Usual with Suicide Rick ManagementParticipants will be randomized to teletherapy sessions with only Suicide Risk Management for PTSD-BPD which will be administered once a week for 6 weeks, for a total of 6 sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-65 years
- Must reside in the Bay Area, CA
- Current DSM-5 diagnosis of PTSD and BPD
- Must be willing to be audio- or videorecorded for assessment and treatment sessions
Key exclusion criteria (4 listed)
- Acute mania, acute psychosis, or intellectual disability
- Conditions requiring medical attention to a potentially life-threatening illness (e.g., severe anorexia nervosa)
- Severe impairments in written and aural comprehension
- EU individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Processing Therapy with Suicide Risk ManagementCPT is an evidence-based treatment for PTSD. This first-line treatment for PTSD will be adapted and combined with SRM into 12 sessions, 60-90 minutes targeting both PTSD and BPD. Individuals assigned to this intervention will attend treatment sessions, and be asked to do treatment homework at home. The primary outcomes are PTSD and BPD severity. | Behavioural | CPT + SRM |
| Treatment as Usual with Suicide Rick ManagementIn the Suicide Risk Management only condition, participants will receive 6 weekly sessions over the course of six weeks focused on suicide stabilization and management. Each SRM session will be variable lengths, depending on the participants' suicide risk and can be up to 60 minutes. | Behavioural | TAU + SRM |
Primary outcome
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Time frame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
A 30-item clinician administered structured interview based on the DSM-5 PTSD criteria.
Borderline Symptom List 23 (BSL-23) [SELF-REPORT]
Time frame: Baseline, once a week while in treatment (for 6 weeks)
A self-report measure of borderline personality disorder (BPD) severity. The measure captures subjective ratings of the following symptoms: self-perception, affect regulation, self destruction, dysphoria, loneliness, intrusions, and hostility (Bohus et al., 2009).
27 secondary outcomes
Suicide Attempt Self-Injury Interview (SASII)
Time frame: 3-weeks, Post-treatment/6-weeks, 3-month follow-up
Difficulties in Emotion Regulation Scale (DERS) [SELF-REPORT]
Time frame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Posttraumatic Cognitions Inventory (PTCI) [SELF-REPORT]
Time frame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Beck's Depression Inventory-II (BDI-II) [SELF-REPORT]
Time frame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
State-Trait Anxiety Inventory, Trait Version (STAI-T)
Time frame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
State-Trait Anger Expression Inventory-II (STAXI-II) [SELF-REPORT]
Time frame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Social Adjustment Scale - Self Report (SAS-SR) [SELF-REPORT]
Time frame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Trauma-Related Guilt Inventory (TRGI) [SELF-REPORT]
Time frame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Suicidal Behaviors Questionnaire-Revised
Time frame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Substance Use Inventory (SUI)
Time frame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
PTSD Checklist-5 (PCL-5) [SELF-REPORT]
Time frame: Baseline, once a week while in treatment (for 6 weeks)
Acceptability of Intervention Measure (AIM)
Time frame: Baseline and Post-treatment/6-weeks
Treatment sessions attended
Time frame: Pre-post treatment (6 weeks)
Rate of dropout
Time frame: Pre-post treatment (6 weeks)
Emotional Reactivity and Attentional Biases via Oddball task
Time frame: Baseline, Post-treatment/6-weeks, 3-months follow-up
Mental Health Involvement Scale [SELF-REPORT]
Time frame: Post-treatment/6-weeks
Measure of CPT+SRM Uptake [SELF-REPORT]
Time frame: 9-months after concluding treatment with the last study participant
Unanticipated Problems Involving Risk to Subjects or Others (UPIRSO)
Time frame: Baseline, 3-weeks, Post-treatment/6-weeks
The International Personality Disorder Exam (IPDE, BPD only)
Time frame: Baseline
The Structured Clinical Interview for the Diagnostic and Statistical Manual-5 (SCID-5)
Time frame: Baseline
The Lifetime Suicide Attempt Self-Injury Interview (L-SASII)
Time frame: Baseline
A Demographic Form [SELF-REPORT]
Time frame: Baseline
Trauma-Related Shame Inventory (TRSI) [SELF-REPORT] Trauma-Related Shame Inventory (TRSI) [SELF-REPORT]: is a 24-item self-report measure that evaluates levels of shame in the context of one's trauma. --
Time frame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Patient Health Questionnaire - 9 (PHQ-9)
Time frame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Generalized Anxiety Disorder - 7 (GAD7)
Time frame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
WHO Disability Assessment Schedule (WHODAS) 2.0 (12-Item Version)
Time frame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure-Adult
Time frame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- BackgroundResick, P. A., Monson, C. M., & Chard, K. M. (2016). Cognitive processing therapy for PTSD: A comprehensive manual. New York, NY: Guilford Press.
- BackgroundStanley, B., & Brown, G. (2012). Safety planning intervention: A brief intervention to mitigate suicide risk. Cognitive and Behavioural Practice, 19(2), 256-264.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice R Kuo, PhD principal investigator
Palo Alto University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Processing Therapy with Suicide Risk Management and Treatment as Usual with Suicide Rick Management in people with Posttraumatic Stress Disorder and Borderline Personality Disorder, run by Palo Alto University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ariana Guenther, B.A. (650-485-1513, bestlab@paloaltou.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) (time frame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04230668, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024; AzTrials last refreshed its copy on 27 Oct 2026.